NCT03453788

Brief Summary

This pilot study is evaluating a new smartphone application named the LETSGO app. The LETSGO app is designed to promote empowerment in patients after treatment for gynecological cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

March 20, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

1.2 years

First QC Date

February 27, 2018

Last Update Submit

September 11, 2019

Conditions

Keywords

follow upside effectssmartphone appphysical activityempowermentpatient reported outcomes

Outcome Measures

Primary Outcomes (1)

  • Satisfaction with LETSGOapp

    Evaluate satisfaction with app through patient interviews

    8 months

Secondary Outcomes (2)

  • Recruitment rate

    6 months

  • Acceptability of goal setting

    8 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Alternating follow-up visits by nurse and doctor. In the nurse-led consultations, the patients will be introduced to the smartphone LETSGOapp with access to information on cancer treatment and side effects, physical activity advice. Two-monthly assessment of 12 symptoms that may represent relapse through the app.The patients will fill in an electronic questionnaire package at baseline, 3, and 6 months after treatment.

Device: LETSGO app

Reference group

NO INTERVENTION

Regular hospital follow-up.The patients will fill in an electronic questionnaire package at baseline, 3, and 6 months after treatment.

Interventions

LETSGO pilot test Group will test LETSGO app and partially nurseled follow-up

Intervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed and treated for gynecological cancer who will be followed up at the gynecological outpatient clinic in Kristiansand or Arendal
  • No cognitive barriers.

You may not qualify if:

  • \< 18 years
  • Not able to read Norwegian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sorlandet Hospital

Kristiansand, Vest Agder, 4604, Norway

Location

Related Publications (1)

  • Skorstad M, Vistad I, Fegran L, Berntsen S, Johannessen B. Nurse-led consultations reinforced with eHealth technology: a qualitative study of the experiences of patients with gynecological cancer. BMC Nurs. 2022 Nov 25;21(1):326. doi: 10.1186/s12912-022-01104-9.

MeSH Terms

Conditions

Motor ActivityEmpowerment

Condition Hierarchy (Ancestors)

BehaviorSocial Behavior

Study Officials

  • Frode Gallefoss

    Chief of Research Department, Sørlandet Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective cohort study with reference group.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 5, 2018

Study Start

March 20, 2018

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

September 12, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

This is a pilot study

Locations